Conversion Study to Optimize Immunosuppressive Regimen by Withdrawal of Steroids, Cyclosporine A Dose Reduction and a Switch to Mycophenolatmofetile for Patients After Heart Transplantation in the Long-Term.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Renal function evaluated by serum creatinine at month 12 and month 24
研究概览
简要总结
The purpose of this study is first to improve or save renal function and second to decrease cardiac risk factors by optimising the immunosuppressive regimen by withdrawing steroids and reducing the Cyclosporine A dose. The concomitant administration of Mycophenolatmofetile, an effective immunosuppressive agent, will minimize the risk of acute rejection episodes.
详细描述
The decrease of quality of life in patients after heart transplantation in the long-term is determined by an increasing incidence of transplant vasculopathy and by immunosuppression-related side effects. Calcineurin inhibitors are associated with chronic nephrotoxicity, while long-term administration of steroids results in an increased incidence of cardiovascular risk factors (e.g. hypertension, lipometabolic disorders, steroid induced diabetes, adipositas)and therefore, carries the potential of graft disfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current immunosuppressive regimen: Cyclosporine A and corticosteroids for at least six month
- •Heart transplantation above 3 years dated back
- •Serum creatinine < 3,5 mg/dl (310 µmol/l) and BUN < 150 mg/dl
- •Cyclosporine A blood level between 50 and 250 ng/ml during the last 12 month
排除标准
- •Carcinoma within the last 3 years
- •Acute rejection episodes during the last 6 month
- •Infection requiring therapeutic intervention
- •Hepatitis B, Hepatitis C or HIV infection
- •WBC < 3000/µl, haemoglobin < 9g/dl, platelets < 70.000/µl
- •Florid gastrointestinal ulcer
- •Haemodialysis within the last 4 weeks before study entry
- •Pregnancy / lactation
- •Administration of other immunosuppressive agents than prescribed
- •Mycophenolatmofetile incompatibility
研究组 & 干预措施
1
prednisolon withdrawal: reduction of maintenance dosage, 0,5 mg of the daily dose every week till withdrawal; Mycophenolatmofetile administration: start doses 250 mg, increase of the daily dose about 250 mg every week till reaching 2 g/daily; Cyclosporin A reduction: 8 weeks after starting prednisolon withdrawal and Mycophenolatmofetile administration reduction of Cyclosporin A trough level till a range from 50 to 90 mg/ml
干预措施: prednisolon (Drug)
1
prednisolon withdrawal: reduction of maintenance dosage, 0,5 mg of the daily dose every week till withdrawal; Mycophenolatmofetile administration: start doses 250 mg, increase of the daily dose about 250 mg every week till reaching 2 g/daily; Cyclosporin A reduction: 8 weeks after starting prednisolon withdrawal and Mycophenolatmofetile administration reduction of Cyclosporin A trough level till a range from 50 to 90 mg/ml
干预措施: Mycophenolatmofetile (Drug)
1
prednisolon withdrawal: reduction of maintenance dosage, 0,5 mg of the daily dose every week till withdrawal; Mycophenolatmofetile administration: start doses 250 mg, increase of the daily dose about 250 mg every week till reaching 2 g/daily; Cyclosporin A reduction: 8 weeks after starting prednisolon withdrawal and Mycophenolatmofetile administration reduction of Cyclosporin A trough level till a range from 50 to 90 mg/ml
干预措施: Cyclosporin A (Drug)
结局指标
主要结局
Renal function evaluated by serum creatinine at month 12 and month 24
时间窗: month 12 and month 24
次要结局
- Cardiovascular risk factors at month 12 and month 24(month 12 and month 24)
- Acute rejection episodes, gastrointestinal disorders and other adverse events at month 12 and month 24(month 12 and month 24)
- Quality of life assessed by the SF36, spiroergometry, concomitant medication at month 12 and month 24(month 12 and month 24)